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Inotropic Treatment With Levosimendan (SimdaxR)in Heart Surgery

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ClinicalTrials.gov Identifier: NCT01221116
Recruitment Status : Terminated (The study was stopped due to difficulties in including patients)
First Posted : October 14, 2010
Last Update Posted : November 2, 2010
Sponsor:
Information provided by:
Ullevaal University Hospital

Brief Summary:
Hypothesis: Treatment with levosimendan will preserve myocardial function and hemodynamics after cardiac surgery and lead to reduced stay at intensive care unit

Condition or disease Intervention/treatment Phase
Heart Failure Cardiac Surgery Drug: levosimendan Not Applicable

Detailed Description:
Single center, prospective, randomized parallel-group, double-blinded study

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Inotropic Treatment With Levosimendan (SimdaxR)in Heart Surgery
Study Start Date : January 2003
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery
U.S. FDA Resources

Arm Intervention/treatment
No Intervention: 1: Type of surgery
Two types of patients are compared (placebo vs levosimendan): CABG - coronary artery bypass grafting and AVR - aortic valve replacement (either with or without CABG - coronary artery bypass grafting)
Drug: levosimendan
levosimendan 0.1 microgram/kg/min) for 24 hours
Other Name: Type of surgery



Primary Outcome Measures :
  1. Need for inotropic agents or IABP (intra aortal balloon pump) [ Time Frame: jan 2003 - dec 2008 ]

Secondary Outcome Measures :
  1. Biochemical, echocardiographic data, Gated SPECT (single photon emission gated tomography) data, laser Doppler data, 24 hour ECG (electrocardiogram) data and clinical "all round" data. [ Time Frame: jan 2003-dec 2008 ]


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • EF (ejection fraction)<40%

Exclusion Criteria:

  • renal failure, liver failure

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01221116


Locations
Norway
Dept. of Cardiothoracic Anesthesia, Ullevål University Hospital
Oslo, Norway, 0407
Sponsors and Collaborators
Ullevaal University Hospital
Investigators
Principal Investigator: Knut A Kirkebøen, MD, PhD Ullevaal University Hospital

Responsible Party: Ullevaal University Hospital, Knut Arvid Kirkebøen
ClinicalTrials.gov Identifier: NCT01221116     History of Changes
Other Study ID Numbers: INSI-study
First Posted: October 14, 2010    Key Record Dates
Last Update Posted: November 2, 2010
Last Verified: January 2003

Keywords provided by Ullevaal University Hospital:
coronary artery disease,
aortic stenosis,
heart failure

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Simendan
Anti-Arrhythmia Agents
Cardiotonic Agents
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Protective Agents
Physiological Effects of Drugs